Device and methods of laser treatment for rhinitis

ABSTRACT

There is provided a process for treatment of rhinitis by diode laser ablation of the posterior nasal nerves. The laser diode delivery device with elongated optic tip is inserted through a patient&#39;s nostril and has the length, flexibility and a curvature to reach both above and under the patient&#39;s middle turbinate for treatment to both posterior nasal nerves. Skin and tissue temperature is raised to approximately 60-65° C. with the process. Optimal treatment wavelength was found to be approximately 380-450 nanometers with blue lasers.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation in part of U.S. patent applicationSer. No. 16/895,951, now U.S. Pat. No. 11,317,970, filed on Jun. 8,2020, which claims the benefit of and priority to U.S. ProvisionalPatent Application No. 62/858,425 filed on Jun. 7, 2020, each of whichare incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates to the field of treatment of rhinitis, andmore particularly to the field of laser treatment of rhinitis.

BACKGROUND

Rhinitis is defined as an inflammatory condition that affects the nasalmucosa. Its symptoms include nasal obstruction, hyperirritability, andhypersecretion. Rhinitis can be caused by a variety of differentallergic and nonallergic conditions. The prevalence of rhinitis seems tohave increased since the industrial revolution. One in five Americans isestimated to be afflicted with rhinitis, totaling about 60 millionindividuals. Allergic rhinitis is one of the most common chronicconditions in the United States. The symptoms of nonallergic rhinitisinclude nasal obstruction, hypersecretion, and irritability, none ofwhich are due to allergy. Nonallergic rhinitis can be furthersubdivided, with vasomotor rhinitis being the most common. The symptomsof vasomotor rhinitis exacerbate with age. Allergic rhinitis may beseasonal, perennial, or both, and is characterized by sneezing, itching,rhinorrhea, and congestion. This study did focus on both allergic andnonallergic rhinitis.

Treatment is initially medical and administered via single ormulti-agent, topical, systemic, or combined methods. Agents includesaline irrigations, topical steroids, topical or systemic adrenergicagents, antihistamine therapy, anticholinergic agents, antileukotrienes,and combinations of these. Drawbacks include tachyphylaxis, reliableefficacy, and the need for constant daily treatment.

Multiple surgical solutions exist with varying degrees of effectiveness.Vidian neurectomy (VN), first described in 1961, was largely abandoneddue to its complexity and complications that included severe bleedingfrom the sphenopalatine artery (SPA), crusting, cheek and palatenumbness, and significant eye dryness. Although VN regained somepopularity with the invention of endoscopic techniques, technicallimitations with the problem of eye dryness remain present. Posteriornasal nerve (PNN) neurectomy, a modification of VN, appeared as a safertechnique due to ophthalmic sparing and the fact that it targets onlythe posterior nasal nerve branches. Resection of the PNN reflects thephysiological elimination of the parasympathetic stimulus to theinferior turbinate as induced by ipratropium, significantly improvingboth rhinorrhea and nasal obstruction. The induced sensory denervationfurther reduces secretagogue generation by reducing neurogenicinflammation. PNN resection appears to be a safe procedure that inducesapparent histological changes and is sustainable for at least 48 months.Thus, selective resection of PNN can be a successful treatment forallergic and non-allergic rhinitis. PNN resection has been performedthrough several methods. Meticulous dissection of the SPA allows foridentification of the nerve, which is found mostly posterior andinferior to the artery, usually while sparing the artery. Recentlydeveloped alternative approach targeting the lateral nasal wall mucosawithout any dissection can also be applied. This can be achieved with acryotherapy device (applied endoscopically to the posterior middlemeatus) that is used to freeze the PNN region, bilaterally. Withoutprecise identification of the nerve, cryotherapy can be done in theoffice, and a follow-up with patients has shown reduction in rhinorrheaand congestion for many months.

SUMMARY OF THE INVENTION

The present invention is a process and device for laser ablation of theposterior nasal nerves (PNN) for the treatment of rhinitis. The laserdiode delivery device with elongated optic tip is inserted through apatient's nostril and has an ability to reach both above and under thepatient's middle turbinate for treatment of both branches of theposterior nasal nerve. Skin and tissue temperature is raised toapproximately 60-65° C. during the treatment process. Optimal treatmentwavelength was found to be approximately 940 nanometers with the presentinvention. In an embodiment, with blue laser and an optimal treatmentwavelength of 380-450 nanometers is used with the present invention byplacing an optical filter in between the camera and the endoscopeconnected to the delivery device in the present invention. The bluelaser has the ability to have unique temperature feedback controlparameters and as a result will temporarily shut off or create pulsingaction (on-off) to maintain the tissue temperature constant until theend of the medical procedure. The inclusion of the optical filter avoidsscattering of the blue laser beam and allows the surgeon to clearly seethe target area.

The process of the present invention for the treatment of rhinitis bylaser ablation of posterior nasal nerves includes ablating the posteriornasal nerves by a diode laser delivery device with an elongateduninitiated clear fiber tip. As the posterior nasal nerves are locatedabove and below a middle turbinate of the patient, the diode laserdelivery device is initially inserted through the patient's nostril andinto an area of tissue near the middle turbinate. In the process of thepresent invention, the laser diode operates at approximately 940nanometers. With the process, the heating of tissue by the device isdone to approximately 60 to 65 degrees Celsius. The tip of the diodelaser delivery device is positioned at a location above the middleturbinate. The process then ablates the lateral posterior superiorbranches of the posterior nasal nerves. By then positioning the tip ofthe diode laser delivery device at a position below the middleturbinate, the process allows the medical professional to ablate thelateral posterior inferior branches of the posterior nasal nerves. In anembodiment of the present invention, the fiber tip of the laser deliverydevice is malleable and is adjustable and capable of configuration toanatomical differences to individual patients. In an embodiment of thepresent invention, the fiber tip of the laser delivery device isdisposable. In another embodiment of the present invention, the laserdelivery device is re-usable. The delivery device for the presentinvention is disposable in another embodiment and the fiber tip isconnected to the disposable delivery device by removable means. Thedelivery device includes a disposable sheath to cover the deliverydevice in an embodiment.

A diode laser ablation of posterior nasal nerves (PNN) study wasperformed: Office based (Topical/Local Anesthesia), N=11; Ambulatory(Sedation/General anesthesia), N=21. Based on the results, there wereshown: Non-allergic 15 pts (47%), Allergic 17 pts (53%). In ASU, whenanatomy does not permit endoscopic access, there is benefit of thepresent invention. There is the added benefits of short treatment time,it is well tolerated by patients with rapid healing, and no crusting.

The 940 nm diode laser ablation thermal profile is used with the presentinvention. Using a clear tip fiber in non-contact mode, tissuetemperature is raised to 65-70 C max to achieve very superficial mucosalblanching and ablate the PNN traveling just under mucosa. By keepingtemperature under 70 C denaturation is achieved, which is partiallyreversible and may be early coagulation, (never vaporization).

With the present invention the advantages of 940 nm diode laser withclear fiber tip are shown. This wavelength is optimal wavelength forablating mucosal surface and provides controlled tissue heating. Theclear fiber tip in non contact mode blanches the mucosa selectivelyeffecting the nerves in sub-mucosa. There is minimal crusting andswelling with the present invention and provides an improved method fortargeting two zones in the back of the nose, targeting the lateralinferior and lateral superior PNNs.

In an embodiment, there is a process for the treatment of rhinitis bylaser ablation of posterior nasal nerves which comprises ablating theposterior nasal nerves by a diode laser delivery device with anelongated clear fiber tip, where the posterior nasal nerves are locatedabove and below a middle turbinate. The diode laser delivery device isinserted into an area of tissue near the middle turbinate with the laserdiode laser delivery device operating at approximately 380 to 450nanometers—a blue laser process. The process heats the tissue toapproximately 60 to 65 degrees Celsius and then the process positionsthe tip of the diode laser delivery device at a position above themiddle turbinate. The process continues by ablating the lateralposterior superior branches of the posterior nasal nerves andpositioning the tip of the diode laser delivery device at a positionbelow the middle turbinate. Then, the process ablates the lateralposterior inferior branches of the posterior nasal nerves.

In an embodiment of the blue laser process, the fiber tip of the diodelaser delivery device is malleable. In an embodiment of the process, thefiber tip of the diode laser delivery device is adjustable and capableof configuration to anatomical differences. In another embodiment of theblue laser process, the fiber tip is disposable. In an embodiment of theblue laser process, the diode laser delivery device is re-usable. In yetanother embodiment, the diode laser delivery device is disposable. In anembodiment, the fiber tip is connected to the disposable diode laserdelivery device by removable means. In another embodiment of the bluelaser process, the diode laser delivery device includes a disposablesheath to cover the diode laser delivery device.

The process, in another embodiment, further comprises selectivelyablating blood vessels with a blue laser in a non-contact coagulationmode. In an embodiment, the process includes wherein the laser diodedelivery device operating at approximately 380 to 450 nanometers furthercomprises an optical filter placed between a camera and an endoscopewhich are connected to the laser diode delivery device. In anembodiment, the process the laser diode delivery device includes a GaNdiode.

BRIEF DESCRIPTION OF THE DRAWINGS

Some embodiments of the invention, and of making and using theinvention, as well as the best mode contemplated of carrying out theinvention, are described in detail below, by way of example, withreference to the accompanying drawings, in which like referencecharacters designate like elements throughout the several views, and inwhich:

FIG. 1 illustrates a procedure of the present invention.

FIG. 2 illustrates a procedure of the present invention with an explodedview.

FIG. 3 is the delivery system for use with the present invention.

FIG. 4 is a chart of the absorption chromaphores molar extinctioncoefficient vs. wavelength.

FIG. 5 is a chart of absorption chromaphores in NIR.

FIG. 6 illustrates 1 second of treatment with clear tip laser device atvarious wavelengths.

FIG. 7 illustrates 2.5 seconds of treatment with clear tip laser deviceat various wavelengths.

FIG. 8 is a chart of coagulation speed with the clean/clear tip laserdevice.

FIG. 9 illustrates 1 second of treatment with a black tip laser devicewith undesirable results.

FIG. 10 illustrates 2.5 seconds of treatment with a black tip laserdevice with undesirable results.

FIG. 11 is a chart of coagulation speed with the black tip laser device.

FIG. 12 is a general reference chart of laser tissue interaction oftemperature, visual change and biological change.

FIG. 13 is a chart of absorption spectra of oxy hemoglobin anddeoxyhemoglobin with emission lines.

FIG. 14 is a chart of absorption against wavelength for various diodelasers.

FIG. 15 is a graph of absorption of lasers with silica fiber in softtissue.

FIGS. 16A and 16B are illustrations of the present invention in use.

FIGS. 17A and 17B are illustrations of the filter of the presentinvention.

FIG. 17C is a schematic of the overall components of the presentinvention.

DETAILED DESCRIPTION

The present invention shall be described with reference to the includedFigures and charts. FIGS. 1 and 2 illustrate the process of treatment ofrhinitis. In FIG. 1 there is shown diode laser ablation of posteriornasal nerves (PNN), with the treatment of lateral posterior superiorbranches of the nerves. The illustration includes a patient 24 and amedical professional 22 holding the diode laser devices 20 for deliveryof treatment to the patient. The handheld laser device 20 with elongatedand needlelike neck 32 culminating in fiber tip 34 is inserted throughthe patient's nostril 30 with the tip 34 of the diode laser deviceextending into the area of the patient's middle turbinate 36. In thearea of the middle turbinate, there are two nerves indicated by the setof branched lines extending from a common point. One nerve (superiorbranch) 40 is located above the middle turbinate and one nerve (inferiorbranch) 42 is located below the middle turbinate. In FIG. 1, the tip ofthe diode laser delivery system is above the middle turbinate 36. Thelateral posterior superior branches 40 are treated in this manner.

In FIG. 2, the tip of the laser diode is inserted below the middleturbinate 36 and ablation occurs here below the middle turbinate. Thisis seen in the exploded view of FIG. 2 where the tip 34 of the laserdiode is set for treatment delivery below the middle turbinate 36 and toreach the lateral posterior inferior branches 42 of the posterior nasalnerves 40, 42. The laser diode treatment operates at approximately 940nanometers with skin/tissue temperature raised up to 60 to 65° C. Theimportant goal is to perform the treatment, but not to destroy thetissue. The surface is heated, but no contact.

The laser diode delivery system in this process is able to reach bothnerves 40, 42 for treatment, as opposed to cryo-technology treatmentswhich are only able to treat a single nerve due to the size of thedevice used in cryo-technology treatment processes.

Referring to FIG. 3, there is shown the laser device 50 and deliverysystem for use with the present invention. The delivery system has fiberof approximately 1.5 m in a modified coupler to laser with 300 μm core.The elongated fiber design 52 is rigid, yet has sufficient curvature atthe tip 54 for positioning and re-positioning by the medicalprofessional without having to withdraw the instrument after insertionfor slight location changes (See, FIGS. 1 and 2). It is positioned incontact with tissue surface and generates 4 watt output at the fibertip. This is with a bare uninitiated fiber tip 54 and should bedistinguished from the black tip technique, which is undesirable withthe present invention as described below. The black tip techniqueincludes a carbon coating on the tip absorbing 30-50% of laser light atthe tip. With the present invention, the fiber tip of the laser deliverydevice is malleable and or made of a malleable material. The fiber tipof the laser delivery device is adjustable and capable of configurationto anatomical differences for each individual patient. The fiber tip isdisposable or alternatively, the delivery device is disposable with thefiber tip connected to the disposable delivery device by removablemeans, such as fasteners, clips, mechanical methods, adhesives. Thedelivery device may also include a disposable sheath to cover thedelivery device. Re-usable delivery devices are also an embodiment ofthe present invention.

In order to determine the optimal methods with the present invention, acomparison of laser diode wavelengths 810, 940 and 980 nm for both cleartip and black tip delivery was analyzed. The results provide avisualization of thermal distribution in biological tissues and acomparison effect of tissue chromaphores. The comparison involved tissuewith high blood content (dark liver was used) and low blood content(pale pork muscle was used).

FIGS. 4 and 5 illustrate the absorption chromaphores of Hb and HbO₂,with the wavelengths of 810 nm, 940 nm and 980 nm indicated in FIG. 5.

With FIGS. 6, 7, and 8, there is shown the effects of the clear tiptechnique which is used with the present invention. FIG. 6 illustratesone second treatment of muscle tissue (top row) and liver tissue (bottomrow) with clear tip treatment. The results are shown for 810, 940 and980 nm, with 940 nm indicating no destruction of tissue. Similarly, FIG.7 illustrates 2.5 second treatment of muscle (top row) and liver tissue(bottom row) with a clear tip delivery device. Again, the results areshown for 810, 940 and 980 nm with 940 nm indicating no destruction oftissue. FIG. 8 indicates the coagulation speed with the clean tip forliver and muscle tissue at each of the wavelengths of 810, 940 and 980nm.

With FIGS. 9, 10, and 11, there is shown the undesirable effects of thedelivery system using the black tip technique as it destroys tissue.This is shown with FIGS. 9 and 10 respectively as images of damagedtissue with 1 second treatment (FIG. 9) and 2.5 seconds treatment (FIG.10) across a range of wavelengths 810 to 980 nanometers for eachtreatment. FIG. 11 indicates the coagulation speed with the blackenedtip.

The observations are reproducible in series (3 times). The high Hbabsorption at 810 nm is higher than theoretical expected as compared to940 and 980 nm. The tissue effect at 940 nm seems to be less dependenton the presence of chromaphores compared to that at 810 and 980 nm for acontrolled coagulation effect. The 940 nm diode laser shows to have acontrolled coagulation/sterilization effect less dependent on thepresence of blood. For 810 nm and 980 nm diode lasers initiate tissuecarbonization and ablation within a few seconds depending on thepresence of chromaphores (especially blood). The pre-coated ‘black tip’is very efficient for instant ablation of tissue within 1 second.

The 940 nm diode laser has a wavelength allowing for controlledsubmucosal thermal penetration. The diode laser is used in both veinligation and neural tissue ablation through a non-contact (notinitiated) type tip. As the vessel ablation requires power settingsaround 12 W, and nerve/brain tissue ablation is induced at 6 W, a powersetting of no more than 5-6 W is sufficient for ablating the endonasalnerves. If the laser's heat is maintained above a certain thresholdtemperature at which proteins begin to denature, the tissue irreversiblycoagulates and the tissue's optical properties (most significantly, theabsorbance properties) change, usually around 60-80 C level. This iseasily monitored by observing the properties of the nasal mucosa, asoverheating may produce vaporization and carbonization, at temperatures100-300 C which are not desired.

Armed with data generated from bench experiments and learning fromvarious disciplines, such as testing diode laser exposure on tissueusing clear (non-initiated) and black (initiated) fiber tips withvarious power densities, the 940 nm laser's potential as a tool in PNNablation was explored. Overall, it is shown that the laser diodedelivery at 940 nm is the best wavelength to ablate and safely coagulatewithout deep penetration and minimal lateral tissue necrosis. A range ofwavelengths around the 940 nm, slightly greater and slightly lesssimilarly provides the results.

The non-contact ablation method with un-initiated fiber tip (Clear tip)at around 4-5 W, gives the best and safe results for superficial tissueablation.

With the present invention, the following clinical study has beenperformed:

Clinical Study Overview:

-   -   Design Prospective, non-randomized    -   Population Healthy patients with rhinorrhea and nasal congestion        who failed medical therapy    -   Primary Endpoint Total Nasal Symptom Score (TNSS) at Baseline,        30, 90 days post treatment    -   Scoring Scales TNSS, validated symptom scale        -   Four nasal symptoms. Rhinorrhea, Nasal obstruction, Nasal            itching, Sneezing        -   0-3 point scale        -   0=Absent symptoms        -   1=Mild symptoms        -   2=Moderate symptoms        -   3=Severe symptoms

Results: Feasibility and Safety

There were 31 patients, with 30 and 90 days follow up received from 30patients. For feasibility, there was an ability to complete theprocedure in 96% of the cases. There were 10 in the office, 21 in theASU due to anatomical access. Topical and/or local anesthesia was usedin the office. The average pain score was 1.8 (scale of 0-10). Forsafety: there was no laser related events, no bleeding, and no crusting,headaches, facial pain or ear blockage.

Results: Efficacy

Symptoms Score 30 Days:

-   -   55% improvement in TNSS    -   Mean score 7.1 (out of 12) at baseline, reduced to 3.2    -   48% improvement in Rhinorrhea    -   Mean score 2.3 (out of 3) at baseline, reduced to 1.2    -   53% improvement in Congestion    -   Mean score 2.1 (out of 3) at baseline, reduced to 1.0        Symptoms Score 90 Days:    -   51% improvement in TNSS    -   Mean score 7.1 (out of 12) at baseline, reduced to 3.5    -   44% improvement in Rhinorrhea    -   Mean score 2.3 (out of 3) at baseline, reduced to 1.3    -   48% improvement in Congestion    -   Mean score 2.1 (out of 3) at baseline, reduced to 1.1        Medication Use    -   70% reduction in medication use at 90 days    -   (Decongestants, antihistamines, steroids, anticholinergics)

Conclusions

Laser ablation of PNN is a well tolerated, safe, office or ambulatoryprocedure. Laser ablation of PNN improves both nasal congestion andrhinorrhea, also reduces medication use. Both allergic and non-allergicrhinitis appears to benefit from Laser Ablation of PNN. The results aresimilar to other treatment modalities. An on going analysis of long termoutcomes in much larger series in a multicenter environment are nextsteps for study.

The Study: Endoscopic, Non-Contact Diode Laser Ablation of the PosteriorNasal Nerve Region in Treating Rhinitis.

Background: Posterior nasal nerve (PNN) surgery, or cryoablation, hasbeen described as an alternative treatment for allergic and vasomotorrhinitis. We hypothesize that endoscopic (diode) laser ablation (ELA) iseffective and less invasive than previously described methods.

Methods: The prospective study was performed with approval from the IRB.Thirty-two patients with chronic rhinitis and nasal congestion resistantto medical management were recruited. Total Nasal Symptom Score (TNSS)measurements were used to assess symptom severity and treatmentoutcomes. ELA was performed in the clinic under topical/local anesthesiain 11 patients, while the remaining 21 were treated under anesthesia inthe operating room. The 400 micron uninitiated diode laser fiber tipwith a malleable protective shaft was specially designed for PNNablation. The fiber was pre-shaped according to the intranasal anatomyand endoscopically advanced toward the posterior middle meatus. The ELAmethod using a 940 nm diode laser at CW 5 W to bilaterally ablate thePNN region. Patients were followed up with for the first at 90 daysafter treatment.

Results: ELA was successfully completed in 97% of patients. No crusting,epistaxis, or other complications were observed. One patient could notbe treated in the office due to limited endoscopic access. TNSS scoreswere reduced by 55% after 30 and by 51% after 90 days (p<0.001).Rhinitis and congestion scores were also decreased at 90 days by 44% and48% respectively after treatment compared to the baseline (p<0.001).

Conclusion: ELA of the PNN region is safe and well tolerated both in theoffice and ambulatory settings. Symptom scores were significantlydecreased after 30 and 90 days. This new minimally invasive methodappears to be a promising alternative to other treatment methods.

Methods

The prospective study was performed with approval from the IRB.Thirty-two patients with chronic rhinitis and nasal congestion(including allergic and non-allergic rhinitis) who were resistant tomedical management were recruited and treated. Patients were treatedeither in the office under topical/local anesthesia or in an ambulatorycenter when intranasal anatomy was not favorable and required generalanesthesia. Particularly apprehensive, poorly cooperative patients withnarrow nasal airway and limited endoscopic visualization to theposterior part of the nose. The Total Nasal Symptom Score (TNSS) waschosen to measure symptom severity and treatment outcomes. The TNSS isthe sum of scores for the symptoms of nasal congestion, sneezing, nasalitching, and rhinorrhea at 30 and 90 days following the procedure, usinga four point scale (0-3) where 0 indicates no symptoms, 1 indicates mildsymptoms that are easily tolerated, 2 is awareness of bothersome buttolerable symptoms, and 3 is reserved for severe, hard to toleratesymptoms that interfere with daily activity. TNSS is calculated byadding the score for each of the symptoms to a total out of 12.Endoscopic laser ablation (ELA) was performed in the office for 11patients, while the rest were treated under sedation in the operatingroom. The 940 nm diode laser (Epic-S, Biolase, Irvine, Calif.) with a400 micron uninitiated malleable fiber tip, which was specially designedfor ablation, was pre-shaped and endoscopically advanced toward theposterior middle meatus. The PNN region was ablated by using acontinuous wave (CW) at 5 W in a noncontact mode for about 15-20seconds. Mucosal blanching represented the end of treatment. ELA wasperformed bilaterally. Patients were followed up for 90 days to assessTNSS. Medication use was also recorded.

Results

All but one patient (96%) were able to complete the procedure. Tenpatients were successfully treated in the office and twenty-one in thesurgical center. Following procedure, pain was recorded on a 1-10 scalefor office-treated patients and was found to be 1.8. No laser safetyevents were recorded. No crusting, headaches, facial pain, eye dryness,palatal numbness, or ear blockage were recorded at any follow-up visits.

Symptom scores after 30 days showed 55% overall improvement in TNSS.Mean score 7.1 (out of 12) at baseline, was reduced to 3.2. Symptomspecific scores showed 48% improvement in rhinorrhea with 53%improvement in nasal congestion after 30 days. Symptom scores 90 dayspost procedure showed 51% overall improvement in TNSS withsymptom-specific scores of 44% improvement in rhinorrhea and 48%improvement in congestion. Total medication use showed 70% reduction inmedication use after 90 days. The results were similar in non-allergic15 (47%) and allergic 17 (53%) patients.

Discussion

In the past, vidian nerve section paved the way to surgical therapy forrhinitis. Ablation of PNN is advantageous for neurectomy considering itsfeasibility and low complication rate. The recent gain in popularity ofcryoablation led to newer studies using alternative technologies totreat the location of the posterior nasal nerves. Studies showedvariation in the number and location of the nerves exiting thesphenopalatine (SP) foramen, with up to 20% branching. Furthermore, someauthors believe that several small foramina exist alongside the nervesexiting the SP foramen, creating an anastomotic network. The branches ofPNN can be found inferior and posterior to the sphenopalatine arterywhere the middle turbinate attaches to the lateral wall, and by locatingthe sphenopalatine artery at the sphenopalatine foramen, followed bytransaction of a thin periosteum covering from the artery, which allowsfor clear vision of the nerve and artery.

To date, the only method of PNN surgery in use was direct identificationunder endoscopic guidance with appropriate nerve section. This methodcan be considered the gold standard. Histological changes are observedwith long-lasting results of up to 48 months in a rat model. EndoscopicPNN section, however, is performed under general anesthesia, is timeconsuming, and requires meticulous dissection.

Cryotherapy, an ablation method of the PNN region, was developed asearly as 1975 and performed with Frigitronics probes (Cooper Surgical,Trumbull, Conn.). The probe reaches −70 C to −90 C and has an effectivethermal treatment radius of up to 3-4 mm as the temperature drops to 0 Cat a 5 mm radius, with tissue necrosis appearing at the given radius.Common complications included epistaxis, nasal obstruction, nasalcrusting, and ear blockage, none of which were reported to be serious.Postoperative bleeding, the most prevalent complication, was readilymanaged post op with topical therapies in most cases. Efficacy showedoverall improvement in symptoms for over 60% of patients, with over 63%improvement in obstructive symptoms and over 77% of patients reportingdecreased rhinorrhea. All but one recent study did not quantify theimprovement. The only report studying TNSS showed improvement, with TNSSreducing significantly after 30 days (mean±standard deviation: 6.2±0.5at baseline, 2.6±0.3 at 30 days, n=27, p<0.001) and a continuedreduction observed after 90 (2.7±0.4, n=24, p<0.001). The new disposabledevice is a single-use ClariFix device (Arrinex, Redwood City, Calif.),which is inserted into the nose and advanced endoscopically to thetarget area, then inflated. Likely due to the fact that the inflationwas in proximity to the Eustachian tube, most patients felt ear fullnessfor a week, with an improvement in 74% of patients. The device'sdisadvantages are its cost and single-location application. Anothercommon side effect is the brain-freeze-type headaches and some mucosalsloughing following the beginning of cryotherapy.

Diode laser PNN ablation as described in this study is a novel methodfor the management of chronic rhinitis that has failed medicalmanagement. As a method in progress, laser PNN ablation showedcomparable results to ClariFix and fewer possible complications. Thelaser has been shown efficacious in the allergic and non-allergicrhinitis groups. Laser ablation enjoys the precision of a malleablefiber tip that can be pre-curved, controlled endoscopically, clearlymapping the PNN target area. In an office setting, the laser fiber canbe more economical as a single-use device. In addition, the laser fibertip can be used for various intranasal procedures, such as turbinatereduction or ablation of swell bodies.

Limitations of the current study include a relatively limited follow-uptime. However, predicting from cryotherapy studies, changes beyond threemonths are limited, and we expect the results to continue to beeffective at a later time. These encouraging results merit a largermulticenter study.

CONCLUSION

Laser PNN ablation is safe and well tolerated both in office and inambulatory settings. Symptom scores were significantly decreased afterboth 30 and 90 days. This new minimally invasive endoscopic method is apromising alternative to other treatment modalities.

Another embodiment of the present invention is described now withreference to FIGS. 13 through 17B. In FIG. 13, there is shown a graph ofhemoglobin and oxyhemoglobin absorption spectra and also showingemission lines of both KTP lasers and blue diode lasers. Blue light isabsorbed by blood, but not by water, and is well suited for treatingblood-rich soft tissues such as mucosa. The thermal tissue effect can betuned in the range from that of potassium titanyl phosphate laser (KTPlaser) to approximately five times stronger. A blue laser can cut andcoagulate tissue at a distance of greater than 2 mm (like KTP laser) andbe used in non-contact mode, which is not possible withelectro/mechanical instruments. The blue diode laser also has theadvantages of substantially lower cost compared to CO₂ laser at the sameor approximately the same efficiency level.

With reference now to FIG. 14, there is shown a chart of the low waterabsorption and high Hgb (blood) absorption typical for blue laser. Theblue laser is made by GaN diodes and cover a wavelength range ofapproximately 380-450 nanometers. Blue lasers have a general rangewavelength of 360-480 nanometers and are within the scope of theinvention. With FIG. 14, there is illustrated how the wavelength of380-450 nanometers is best one to use over red colored mucosa and bloodvessels of a patient, given the low water absorption and high bloodabsorption.

FIG. 15 illustrates a chart of how blue lasers are absorbed with silicafiber in soft tissue. The GaN diode laser absorption is on the left sideof the chart with absorption shown for 1% blood, 5% blood, 10% blood,and 75% water. The lasers at 400-500 nm made by GaN diodes are deliveredby silica fiber transmitted through soft tissue and blood absorption.There is zero/minimal absorption by water.

The current clinical prototype is as follows: a wavelength of 445 nm isused, with an average power of up to 17 Watts and with a peak power ofup to 30 Watts. The GaN blue diode laser (405-450 nm) with coefficientof absorption 10-150 cm−1 can be used for non-contact/focused beamcutting and vaporization similar to CO₂ laser in super pulse mode: 10-20W peak power and 1-10 W average power.

There has been a noted disadvantage of applications of a blue laseraccording to specialists from Pavlov First Saint Petersburg StateMedical University. During the clinical trials one disadvantage of bluelaser was discovered—a glass filter must be used to reduce thescattering illumination of the surgical field. Working with a rigidendoscope connected to the camera was therefore practically impossibledue to the bright blue light of the emission and the absence of thelight filter. It was possible to work only with short single pulses.This is a significant problem as rigid endoscopes are used for mostoperations in the nasal cavity.

Referring to FIGS. 16A and 16B, there is shown the solution providedwith the embodiment of the present invention. The present invention usesan optical filter (for 445 nanometers) of transparent material, glass,polymer etc., that is positioned between the camera and the endoscope inconnection with the delivery device described previously. The housingrim 100 with optical filter 103 between is placed between the camera andthe endoscope at this position to avoid scattering of the laser beam andto allow the surgeon to clearly see the target area. This presentinvention is suitable for use with methods and delivery devicesdescribed earlier herein. In FIG. 16A there is shown the rim/housing 100which supports the optical filter 103 (See also FIGS. 17A and 17B), nextto a measuring ruler 102 to provide the approximate dimensions, lessthan one inch (or less than 2.5 cm) outer diameter and less than onecentimeter for the inner diameter opening which holds optical filter103. In an embodiment, the dimension of the ring housing (the 7 mmfilter) should be approximately 3 cm to fit the camera and endoscopeassembly showing in FIG. 16B. In FIG. 16B, the rim 100 supportingoptical filter 103 is placed over opening 105 within endoscopic camerahousing 106 and camera locking system collar 108. The camera lockingsystem 108 keeps the endoscope locked to the camera head. Once the rim100 with filter 103 is in place so that filter 103 aligns over opening105, the endoscopic camera housing 106 and camera locking system collar108 are assembled with the endoscope head piece 104 placed over theassembly. The delivery device described above is connected to theendoscope and camera assembly so the blue laser light is deliveredduring the medical procedure.

With reference to FIGS. 17A and 17B, there is provided an isolated viewof a filter which is used with the present invention. In an embodiment,a 445 nm optical filter was created using a glass filter ofapproximately 7-8 mm from Omega Optical of Brattleboro, Vt. In FIG. 17A,there is shown the optical filter 200 with glass or optical piece 202inside the filter and placed next to a ruler 204, which indicates anapproximate diameter of less than 1 cm. In FIG. 17B, a handmade housing210, formed from pressed thick foam, was used to hold the optical filter200. Metals, composites, plastics, or other suitable materials may beused for the housing. The housing 210 has an outer circumference 212 andan inner circumference 214 defining a center opening 216. The opticalfilter 200 is placed within foam housing 210 in the center opening 216where it is held and surrounded by the inner circumference 214. Thishousing 210 is then placed between the endoscope and the camera head asillustrated before in FIG. 16B. A non-limiting table of specificationsof optical filters which may be included for use in the presentinvention is presented below. Information is provided for the filters asboth a light source and as a detector.

Light Source Detector Spectral Cut On 460 nm 460 nm PeakTransmission - >85% >85% Min. acceptable % Attenuation Range - UV-450 nmUV-450 nm short to long wavelengths Attenuation OD - OD5 OD5 short tolong average average wavelengths Physical Size/Diameter 7.5 + 0/−.25 mm9.5 + 0/−.25 mm (mm) Thickness: 1.1 +/− 0.1 1.1 +/− 0.1 (Max) (mm) RingMounted unfinished unfinished

FIG. 17C illustrates the components of the system 150 of the presentinvention. The filter 156 described above is shown between the endoscope154 and the camera 158. These are connected with the delivery device 152described previously for performing the procedures and process of theinvention.

With the PNN process specifically performed with a blue laser in thepresent invention, the medical professional/surgeon can see the bloodvessels with the endoscope and since the tiny PNN nerves are runningalong the blood vessel(s), the surgeon is able to selectively ablate theblood vessels with the blue laser in non-contact coagulation mode. Thisselective ablation method minimizes the damage, improves the outcome,and is a unique aspect of the blue laser. This is not and cannot be donewith other lasers, RF or cryo-based means, or other current methodscommercially available. Also, the 940 nm wavelength described hereindoes not have such selective Hgb absorption characteristics.

With the blue laser, during the process of the invention, the heating ofthe mucosal surface ideally should be approximately 60-65 Celsius toachieve reversible coagulation effect. Further, the blue laser hastemperature feedback control parameters, which is a particular featureto the blue laser. As a result, the laser temporarily shuts off orcreates pulsing action (on-off) to maintain the tissue temperatureconstant until the end of the procedure. The blue laser has superiortemperature control on tissue, selectivity to red colored mucosa surfaceand is highly absorbed by blood Hgb).

While illustrative embodiments of the invention have been describedabove, it is, of course, understood that many and various modificationswill be apparent to those of ordinary skill in the relevant art, or maybecome apparent as the art develops. Such modifications are contemplatedas being within the spirit and scope of the invention or inventionsdisclosed in this specification.

What is claimed is:
 1. A process for the treatment of rhinitis by laserablation of posterior nasal nerves comprising: ablating the posteriornasal nerves by a diode laser delivery device with an elongated clearfiber tip, said posterior nasal nerves located above and below a middleturbinate; said diode laser delivery device inserted into an area oftissue near said middle turbinate; said laser diode laser deliverydevice operating at approximately 380 to 450 nanometers; heating saidtissue to approximately 60 to 65 degrees Celsius; positioning said tipof said diode laser delivery device at a position above said middleturbinate; ablating lateral posterior superior branches of saidposterior nasal nerves; positioning said tip of said diode laserdelivery device at a position below said middle turbinate; ablatinglateral posterior inferior branches of said posterior nasal nerves. 2.The process according to claim 1, wherein said fiber tip of said diodelaser delivery device is malleable.
 3. The process according to claim 1,wherein the fiber tip of said diode laser delivery device is adjustableand capable of configuration to anatomical differences.
 4. The processaccording to claim 1, wherein said fiber tip is disposable.
 5. Theprocess according to claim 1, wherein said diode laser delivery deviceis re-usable.
 6. The process according to claim 1, wherein said diodelaser delivery device is disposable.
 7. The process according to claim6, wherein said fiber tip is connected to said disposable diode laserdelivery device by removable means.
 8. The process according to claim 1,wherein said diode laser delivery device includes a disposable sheath tocover said diode laser delivery device.
 9. The process according toclaim 1 further comprising selectively ablating blood vessels with ablue laser in a non-contact coagulation mode.
 10. The process accordingto claim 1 wherein said laser diode delivery device operating atapproximately 380 to 450 nanometers further comprises an optical filterplaced between a camera and an endoscope which are connected to saidlaser diode delivery device.
 11. The process according to claim 1wherein said laser diode delivery device includes a GaN diode.